Smart cap approved for disposal insulin injector pens
The FDA granted 501(k) clearance to a smart cap sensor for disposable insulin pens, according to an industry press release.
Mallya (Biocorp) is a device that attaches directly to pen injectors to collect and record treatment information, including dose, date and time of injection, and transmit the data via Bluetooth to a dedicated digital application.
The device is currently approved in Europe and is the first system approved in the United States able to automatically connect to different types of pen injectors for insulin and GLP-1 drugs, with initial compatibility with Sanofi’s Solostar pen injectors, according to the release.
“This approval is a major achievement for BIOCORP and all of our employees who have been heavily involved in this regulatory process,” Eric Dessertenne, CEO of BIOCORP, said in the press release. “This approval marks a historic achievement for BIOCORP as it allows the commercial launch of our Mallya device in the United States and illustrates BIOCORP's ability to meet the highest regulatory requirements.”
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